The Mighty Logo

Sana Health Set For Largest Non-Drug Clinical Trial To Manage Symptoms of Fibromyalgia

Sana Health is working to provide relief for millions of people affected by Fibromyalgia, with the largest non-drug user study ever set to begin on the Sana device. See if you qualify to receive a Sana device and participate in the study here.

For nearly 10 million Americans, the pain and discomfort from Fibromyalgia symptoms can significantly impact quality of life. Now, Colorado-based Sana Health, Inc hopes to offer relief to those living with Fibromyalgia symptoms through their audiovisual Sana Device. The company will soon launch a 1,000-person study for use of the Device in Fibromyalgia, the largest non-drug study ever conducted. This user study is being completed in tandem with several clinical trials.

Fibromyalgia causes pain and a range of symptoms throughout the body. Current treatments include a combination of medications, physical and occupational therapies, cognitive behavioral therapy, and lifestyle management. This is often ineffective, and new research and treatment is needed. Briony, from The Mighty’s Fibromyalgia community, shared her experience with treatment, “I have tried everything under the sun to have even the tiniest bit of relief from the pain, but nothing works, so I suffer every second of every day in excruciating pain and there’s nothing I can do about this.”

The Mighty is assisting Sana Health in recruitment for their user study for individuals in the U.S. diagnosed with Fibromyalgia who are seeking new options for symptom management. See if you’re eligible to try their device here.

The device is a comfortable eye mask and earbud combination which gently uses audiovisual stimulation (AVS) to guide the wearer into a state of relaxation. Clinical data from Sana device treatments show that targeted AVS impact the central nervous system.

In a 16-minute session, the Sana device provides a patented series of light and sound pulses, alternating eye-to-eye and ear-to-ear. These sessions can be done at home through an app paired to the device.

As the algorithm moves through three phases the user relaxes into a deeper meditative state. At the conclusion, individuals feel very relaxed and some fall asleep.

Richard Hanbury, founder and CEO of Sana developed the Sana device after a Jeep accident in 1992 in Yemen left him with a spinal cord injury and chronic pain. After 14 months in the hospital, he was given a life expectancy of just five years. To address his own pain, he began to experiment with biometric sensors and neuromodulation patterns, hoping to recalibrate how his brain processed pain signals.

The earliest prototype of the Sana device helped relieve his symptoms, and he went on to test it with the British and U.S. military services, Richard Branson’s Virgin Challenger flights, and the first Solar Impulse Flights. In 2016 he founded Sana Health to bring the technology to others who need it. “The therapeutic program provided in the 16-minute Sana session was refined over more than 25 years of trial and error by founder and inventor Richard Hanbury, in collaboration with neuroscientist Jeffrey Bower, PhD, who used EEG readings to validate the findings,” Sana Health told The Mighty.

Users of the Sana device are finding relief for a range of symptoms, including pain, mood, and sleep disturbances. The device is breakthrough technology for anyone seeking non-drug treatment for symptoms related to Fibromyalgia. In fact, Sana has been awarded the status of Breakthrough Device Designation for the Sana device, for use in Fibromyalgia, from the Food and Drug Administration (FDA). This indicates that early testing shows that the device provides clinically meaningful improvement in symptom management for Fibromyalgia. With this status, Sana will receive priority when they submit Fibromyalgia studies for FDA approval.

Users of the device speak well of its results. Jessica is a 44-year-old mother with Fibromyalgia, ankylosing spondylitis, and cancer. Her conditions left her fatigued and stressed, sleeping up to 16 hours a day at times. Regular use of the Sana device has helped her get better rest and left her with more energy. “With Sana, I am able to participate in life,” she said. “Something is centering me and something is grounding me. I can be in the moment.”

The Mighty is excited to be able to assist Sana Health in recruiting patients into this landmark user study, and in the promise of this technology to help those managing Fibromyalgia. If you’ve been diagnosed with Fibromyalgia and would like to learn more about how to participate in the study with Sana, see if you qualify here.

Conversations 19